Clinical Trial MO25743:

Trial:

An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases.

Purpose:

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in patients with metastatic melanoma who developed brain metastases. Patients may or may not have received prior treatment for metastatic melanoma with brain metastases (except treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Key Inclusion Criteria:

• Adult patients > 18 years of age
• Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
• Measurable brain metastases, treated or untreated
• Patients may or may not have received prior systemic therapy for metastatic melanoma and either (a) have received no prior treatment for brain metastases; or (b) have received prior treatment for brain metastases and have progressed
• Patients may or may not have symptoms related to their brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

Key Exclusion Criteria

• Increasing corticosteroid dose during the 7 days prior to first dose of study drug
• Leptomeningeal involvement in patients with no prior treatment for brain metastases
• Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
• Concurrent administration of any anticancer therapies other than those administered in the study
• Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy 2 weeks prior to first dose of study drug
• Prior treatment with BRAF or MEK inhibitors
• Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Trial Information

Victoria: Peter MacCallum Cancer Centre
PI: Prof Grant Arthur

New South Wales: Westmead Hospital
PI: Prof Richard Kefford
e: richard.kefford@sydney.edu.au

Please contact the clinical trials unit at: MelanomaCTUResearchNurses@petermac.org

Clinical Trial NO25390:

Trial:

An open-label, multicenter, single-arm, phase I dose escalation with efficacy tail extension study of RO5185426 in paediatric patients with surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAF V600 mutations.

Purpose:

Open-label, multicentre, single-arm, phase I dose escalation study of RO5185426 in paediatric patients (aged 12-17) with newly diagnosed or recurrent histologically confirmed surgically incurable and unresectable stage IIIC or stage IV (AJCC) melanoma harboring BRAF V600 mutations as determined by the cobas ® 4800 BRAF V600 mutation test.

Key Inclusion Criteria:

• >12 through <17 years
• Karnofsky (for patients >16yrs) or Lanksy (for patients <16yrs) of >60
• Histologically confirmed surgically incurable and unresectable stage IIIC or Stage IV (AJCC) melanoma
• Measurable disease according to RECIST 1.1

Key Exclusion Criteria:

• Active or untreated CNS lesions
• Previous treatment with selective/specific BRAF or MEK inhibitor (previous sorafenib allowed)

 Trial Information

Queensland – Private Practice Royal Childrens
PI: Dr Timothy Hassall
Ph: (07) 3636 8111

New South Wales – Westmead Children’s Hospital
PI: Prof Geoffrey McCowage
Ph: (02) 9845-2141
e:Geoff.mccowage@health.nsw.gov.au